FDA 510(k)

Clarifi Imaging System

K-Number: K181623 · 2018-07-19

Decision Date2018-07-19

Product CodeMUD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Clarifi Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Modulated Imaging, Inc.. It received FDA 510(k) clearance on 2018-07-19 under 510(k) number K181623. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clarifi Imaging System?

Clarifi Imaging System is a medical device that received FDA 510(k) clearance on 2018-07-19. The listed applicant is Modulated Imaging, Inc.. The 510(k) number is K181623.

When did Clarifi Imaging System receive FDA 510(k) clearance?

Clarifi Imaging System received FDA 510(k) clearance on 2018-07-19, under 510(k) number K181623.

Who is the listed applicant for Clarifi Imaging System?

The FDA 510(k) record lists Modulated Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clarifi Imaging System?

The FDA product code for Clarifi Imaging System is MUD.

Other records listing Modulated Imaging, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.